Lung CancerNCT05620329
UNC Pleural Fluid Registry
An observational study of Lung Cancer and Lung Infection, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
Research with biospecimens such as blood, tissue, or body fluids can help researchers understand how the human body works. Researchers can make new tests to find diseases, understand how treatments work, or find new ways to treat a disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Lung Infection, Breast Cancer
- How many people
- 9,999 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2018to 24 Jan 2050
- How long will I take part?
- 32 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: UNC patients
Who may be able to join
- Patients who are 18 years or older
- Inpatients and outpatients
- Diagnosed with pleural fluid, are referred for and undergo clinically indicated drainage who have clinical evidence of:
- pulmonary infection (such as fever, leukocytosis, new or worsening infiltrate on chest x-ray, or clinical deterioration) with effusion
- malignancy
Who cannot join
- A subject will not be eligible for inclusion in this registry if, in the investigator's (or treating clinician's) opinion, the patient has any concurrent medical condition that may preclude their ability to undergo pleural fluid drainage safely.
- Incarcerated individuals
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UNC Lingeberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Carmmen Garcia, 919-966-4432, carmmene@med.unc.edu
Luz Cuaboy, luz_cuaboy@med.unc.edu
About this study
Official title: University of North Carolina Pleural Fluid Registry
Research with biospecimens such as blood, tissue, or body fluids can help researchers understand how the human body works. Researchers can make new tests to find diseases, understand how treatments work, or find new ways to treat a disease. The purpose of this study is to collect biospecimens for research from patients with known or suspected lung cancer. The information learned from the biospecimens may be used in future treatments. The purpose of this protocol is to create a pleural fluid registry for use in future studies.
- Conditions
- Lung Cancer, Lung Infection, Breast Cancer, Malignant Pleural Effusion, Empyema
- Keywords
- biospecimen, pleural fluid, lung cancer, cancer, infection, breast cancer
- Medical subject headings
- Lung Neoplasms, Breast Neoplasms, Pleural Effusion, Malignant, Empyema, Neoplasms, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pleural Fluid Registry | Any subject who has pleural fluid buildup from lung cancer, breast cancer, or lung infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation of a pleural fluid registry
Biological specimens and corresponding clinical data from subjects will be collected during standard of care procedures and medical record abstraction to support the creation of a pleural fluid registry.
Measured: 32 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start24 Jan 2018
- Primary completion24 Jan 2050 (estimated)
- Study completion24 Jan 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9,999 participants (estimated)
- Target duration
- 32 Years
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Akulian, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620329
- Sponsor's protocol ID
- LCCC1754
- Status last verified
- Oct 2026
- First submitted
- 9 Nov 2022
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- University of North Carolina Pleural Fluid Registry
- ClinicalTrials.gov ID
- NCT05620329
- Acronym / sponsor ID
- LCCC1754
- Conditions
- Lung Cancer, Lung Infection, Breast Cancer, Malignant Pleural Effusion, Empyema
- Keywords
- biospecimen, pleural fluid, lung cancer, cancer, infection, breast cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 9,999 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 24 Jan 2018 (actual)
- Primary completion
- 24 Jan 2050 (estimated)
- Study completion
- 24 Jan 2050 (estimated)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research with biospecimens such as blood, tissue, or body fluids can help researchers understand how the human body works. Researchers can make new tests to find diseases, understand how treatments work, or find new ways to treat a disease. The purpose of this study is to collect biospecimens for research from patients with known or suspected lung cancer. The information learned from the biospecimens may be used in future treatments. The purpose of this protocol is to create a pleural fluid registry for use in future studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 32 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pleural Fluid Registry | – | –Any subject who has pleural fluid buildup from lung cancer, breast cancer, or lung infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- UNC patients
Key inclusion criteria (5 listed)
- Patients who are 18 years or older
- Inpatients and outpatients
- Diagnosed with pleural fluid, are referred for and undergo clinically indicated drainage who have clinical evidence of:
- pulmonary infection (such as fever, leukocytosis, new or worsening infiltrate on chest x-ray, or clinical deterioration) with effusion
- malignancy
Key exclusion criteria (2 listed)
- A subject will not be eligible for inclusion in this registry if, in the investigator's (or treating clinician's) opinion, the patient has any concurrent medical condition that may preclude their ability to undergo pleural fluid drainage safely.
- Incarcerated individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Creation of a pleural fluid registry
Time frame: 32 years
Biological specimens and corresponding clinical data from subjects will be collected during standard of care procedures and medical record abstraction to support the creation of a pleural fluid registry.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to share IPD with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason Akulian principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Lung Infection, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carmmen Garcia (+1 954-336-7499, carmmene@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creation of a pleural fluid registry (time frame: 32 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.